Associate Manager - Quality Control

Overview

The Associate Manager of Quality Control oversees all QC operations within a pharmaceutical manufacturing plant. This role is pivotal in guaranteeing that raw materials, in-process items, and finished pharmaceuticals comply with stringent quality standards and regulatory mandates like GMP, GLP, WHO, and local authorities such as NAFDAC.

Primary Duties

• Supervise QC laboratory functions entailing chemical, microbiological, and instrumental testing.
• Conduct assessments of raw materials, packaging, intermediate samples, and final products adhering to validated methods and specifications.
• Approve laboratory results including certificates of analysis and formal test reports.
• Ensure full adherence to applicable regulatory frameworks and quality policies.
• Manage calibration, qualification, and upkeep of analytical instruments and lab equipment.
• Lead inquiries and documentation related to Out-of-Specification, Out-of-Trend results, and other deviations, ensuring resolution and compliance.
• Prepare, assess, and revise SOPs, test methods, and specifications.
• Coordinate stability study processes with accurate reporting and documentation.
• Oversee mentoring, training, and performance evaluation of QC team members.
• Maintain data integrity and proper record-keeping in line with compliance expectations.
• Facilitate internal and external audits and regulatory inspections.
• Collaborate cross-functionally with Production, Quality Assurance, and other departments to uphold quality and conformity.
• Monitor stock levels of laboratory reagents and consumables, ensuring uninterrupted testing activities.

Qualifications & Experience

• Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, or related discipline; advanced degree preferred.
• At least 10 to 15 years of relevant experience in pharmaceutical manufacturing, including 3 to 5 years in managerial capacity.
• Robust understanding of GMP, GLP, and regulatory standards such as those from NAFDAC and WHO.
• Proficiency with analytical instruments including HPLC, Gas Chromatography, UV Spectrophotometer, among others.
• Strong leadership, organizational capabilities, and effective problem-solving aptitude.
• Excellent verbal and written communication skills focused on technical reporting.
• Keen attention to detail and a dedicated approach to maintaining quality assurance.

Key Competencies

• Leadership and people management
• Analytical reasoning and critical evaluation
• Compliance with regulatory standards
• Meticulousness and thoroughness
• Effective decision-making
• Efficient time management